Samantha Lynn, Inc recalls Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Recalled December 5, 2012 · FDA recall D-063-2013 · Samantha Lynn
Hazard
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug. · FDA Class I
Units
25,888 Boxes
Sold at
Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
Description
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Product
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Manufacturer(s)
Samantha Lynn, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →